510(k) · Cleared
Recalled · Class II · 2013Crono Five and Crono Pca 50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cane S.R.L. · FRN Pump, Infusion
Cleared on Nov 23, 2005 as substantially equivalent to K041414 (Cane S.R.L., 2004) after a 100-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 23, 2005
- Review
- 100 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982838 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK982838 Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400Sims Deltec, Inc. · 1998 · Recalled
- 2 generations backK013234 Microjet CronoCane S.R.L. · 2002
- 1 generation backK041414 Crono and Crono, Model 30Cane S.R.L. · 2004 · Recalled
- This deviceK052218 Crono Five and Crono Pca 50Cane S.R.L. · 2005
- Descendant · cites it directly · 1 of its ownK091042 Crono S-Pid 50Cane S.R.L. · 2009
- Descendant · 2 generations on · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982838 | Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400 | Sims Deltec, Inc. | 1998 | 2 |
| −2 | K013234 | Microjet Crono | Cane S.R.L. | 2002 | — |
| −1 | K041414 | Crono and Crono, Model 30 | Cane S.R.L. | 2004 | 1 |
| 0 (this device) | K052218 | Crono Five and Crono Pca 50 | Cane S.R.L. | 2005 | — |
| +1 | K091042 | Crono S-Pid 50 | Cane S.R.L. | 2009 | — |
| +2 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041414 | Crono and Crono, Model 30Summary page 1…mmon/Usual Name: Ambulatory Infusion Pump. 2. Equivalent legally marketed devices This product is similar infunction and design to the Crono cleared under 510(k) number K041414. 3. Indications for Use (intended use) The portable Crono Five and Crono PCA 50 infusion devices have been designed for use in s… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091042 | Crono S-Pid 50 | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2013 | Class II | Z-0099-2015 | Device Design | Product has the potential to have a clear debris on the tip of the needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K091042 (Cane S.R.L., 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K041414.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052218: Crono Five and Crono Pca 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026